Evaluating Patients With Eye Allergies and Determining if There Are Also Dry Eyes

June 2, 2016 updated by: Marc R.Bloomenstein, Schwartz Laser Eye Center

Concomitant Dry Eye in Patients With Ocular Allergy: an Under Recognized and Poorly Managed Syndrome

Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Schwartz Laser Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be screened from existing patient database.

Description

Inclusion Criteria:

  • Ability to give informed consent
  • Males and females at least 18 years of age
  • Personal history of allergic disorders including but not limited to allergic conjunctivitis, allergic rhinitis, contact dermatitis and other eczema, and asthma
  • Diagnosis of allergic conjunctivitis
  • Presence of any of the following signs including conjunctival redness and papillae, chemosis, red edematous eyelids, reduced tear clearance, reduced TBUT, vital staining, stringy discharge, and/or symptoms including ocular itching, burning and tearing, runny nose or itchy throat

Exclusion Criteria:

  • Active ocular or systemic infection
  • History of ocular infection within past 6 months
  • Presence of punctal plugs
  • Recent ocular surgery within past 6 months
  • Current use of chemotherapeutic agents
  • Presence of ocular trauma
  • Inability to give informed consent
  • Women who are pregnant, nursing or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Dry Eyes, Eye Allergies
Patients with ocular allergies and those with dry eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of dry eye in an allergic population presenting to a high volume optometry practice
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of allergic patients with moderate to severe ocular signs and symptoms
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schwartz Laser Eye Center

Collaborators

Allergan

Investigators

  • Principal Investigator: Marc R Bloomenstein, O.D., Schwartz Laser Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 20, 2012

First Submitted That Met QC Criteria

August 30, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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